Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks

NCT07763782 | Not Yet Recruiting

• 1 other identifier: IRB00014233-94
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

investigates the comparative effectiveness of two interventions aimed at promoting the healing of venous leg ulcers-a common chronic condition characterized by impaired venous return and poor wound healing in the lower extremities. The research explores whether structured and supervised calf muscle pump activation exercises, delivered with individualized dose-response protocols, can enhance venous return and improve ulcer healing outcomes more effectively than traditional recommendations for unsupervised home walking. The structured intervention likely involves targeted exercises designed to optimize the activation and function of the calf muscle pump, which is crucial for facilitating blood flow from the legs back to the heart. In contrast, the unsupervised home walks represent a less controlled, patient-led approach often prescribed in clinical practice. By comparing these approaches, the study seeks to determine if a more scientific, structured exercise regimen tailored to each patient's response yields superior healing rates, better compliance, and improved patient quality of life. Ultimately, the findings may inform best practices for physical therapy and rehabilitation strategies in the management of venous leg ulcers, potentially leading to more personalized and effective treatment protocols in clinical and home settings.

Conditions

Venous Ulcer of Leg

Keywords

wound healing; leg ulcer; calf pump

Outcome Measures

Primary Outcomes (2)

• wound healing volume (cm3))

  saline injection

  at base line and 12 weeks

• wound healing (surface area(cm2)

  using Image J software

  at base line and 12 weeks

Secondary Outcomes (2)

• Venous Filling Index (VFI) (mL/sec)

  at baseline and 12 weeks

• Ejection Fraction (EF) (%).

  at base line and 12 weeks

Study Arms (2)

Group A: Dose-Response Structured CMP Activation Strategy

EXPERIMENTAL

Weeks 1-4 (Activation Phase): Focuses on establishing baseline mobility. Weeks 5-8 (Hypertrophy \& Ejection Phase): Focuses on building muscle pump volume. Weeks 9-12 (Power \& Hemodynamic Clearance Phase): Focuses on clearing pooled blood under high pressure.

Other: Dose-Response Structured CMP Activation

Group B: Unsupervised Home Walking (Active Control)

ACTIVE COMPARATOR

Completely independent and self-managed home program

Other: Active Control

Interventions

Dose-Response Structured CMP Activation OTHER

Progression Protocol (The Dose-Response) Weeks 1-4 (Activation Phase): Focuses on establishing baseline mobility. Ankle ROM Drills: 3 sets of 15 repetitions of passive and active dorsiflexion/plantar flexion stretches utilizing an inelastic stretching strap. Goal: Overcome joint stiffness to reach \>10° of passive dorsiflexion. Seated CMP Loading: Seated heel raises with resistive elastic bands (15 repetitions, 4 sets). Weeks 5-8 (Hypertrophy \& Ejection Phase): Focuses on building muscle pump volume. Standing Closed-Kinetic Chain Exercises: Standing bodyweight heel raises performed on a step to allow a deep negative heel deficit (eccentric loading). 4 sets of 12 repetitions. Incline Ergometry: 15 minutes of continuous stationary cycling or treadmill walking at a 5% to 8% incline to force a natural heel-strike and powerful toe-off phase. Weeks 9-12 (Power \& Hemodynamic Clearance Phase): Focuses on clearing pooled blood under high pressure. Resisted Plantarflexion: Single-leg standing hee

Group A: Dose-Response Structured CMP Activation Strategy

Active Control OTHER

Patients were issued a medical-grade wrist-worn pedometer and a matching ankle sensor. The device display was blinded (blacked out) to prevent active self-biasing or behavioral modification based on step count numbers. Data was downloaded retroactively by researchers at bi-weekly clinic visits to measure real-world gait speeds, step counts, total active time, and spatial asymmetries without the patient altering their natural routine. No constraints were placed on gait modifications. If the patient guards their wound by walking flat-footed or shuffling, the behavior is recorded but not corrected, providing a true representation of unguided real-world walking mechanics.

Group B: Unsupervised Home Walking (Active Control)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age (ge 20 - 60) years with a confirmed, non-healing VLU (present for \\(\>6\\) weeks).
• Ulcer surface area between \\(2 \\text{ cm}\^2\\) and \\(20 \\text{ cm}\^2\\).
• Ankle-Brachial Index (ABI) \\(\\ge 0.8\\), ensuring adequate arterial perfusion.

You may not qualify if:

• Severe, uncompensated congestive heart failure (NYHA Class III or IV).
• Active local wound infection or systemic osteomyelitis.
• Deep vein thrombosis (DVT) diagnosed within the past 3 months.
• Severe osteoarthritic limitations rendering ankle movement impossible.

Sponsors & Collaborators

• MTI University: lead

MeSH Terms

Conditions

Varicose Ulcer; Leg Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: RCT

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 13, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 5, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share